Pest Management Standards For Food Plants - National Pest ...
Pest Management Standards For Food Plants - National Pest ...
Pest Management Standards For Food Plants - National Pest ...
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2010<br />
NATIONAL PEST MANAGEMENT ASSOCIATION<br />
<strong>Pest</strong> <strong>Management</strong><br />
<strong>Standards</strong> <strong>For</strong><br />
<strong>Food</strong> <strong>Plants</strong><br />
1
<strong>Pest</strong> <strong>Management</strong><br />
<strong>Standards</strong> <strong>For</strong> <strong>Food</strong> <strong>Plants</strong><br />
i
INTRODUCTION<br />
e are pleased to release the 2010 <strong>Pest</strong> <strong>Management</strong> <strong>Standards</strong> for <strong>Food</strong> <strong>Plants</strong>,<br />
Wa cornerstone of NPMA’s Commercial Division activities since 2007.<br />
In 2009, NPMA witnessed the evolution of the allergen issue and issued a revised<br />
standard, 2.14. This is incorporated with 2009 changes into this version.<br />
As always, hese standards also DO NOT preempt local, state, provincial, and/or federal<br />
regulations. Any service provided must comply with government regulations or statutes<br />
governing pest management, safety, and food protection. In addition, food plants may<br />
have requirements more stringent than these standards.<br />
<strong>Pest</strong> management firms embracing the standards have raised the professionalism and<br />
technical abilities to secure the industry role as protectors of food. With the standards, a<br />
comprehensive testing site which provides all pertinent information at www.npmatesting.<br />
com, and the study guide as well as other resources noted in the standards, NPMA has<br />
provided the tools necessary to comply with the standards and to raise the level of<br />
competency of professionals servicing food plants.<br />
As of the date of publication, well over 3,000 technicians have take the exam prepared as<br />
a companion to these standards. That is a credit to the industry’s striving to provide the<br />
best possible service.<br />
We hope that you find these standards a beneficial addition to your own company<br />
protocols and procedures. As protectors of food it is our obligation to exceed<br />
expectations and to see our role as a vital component to overall food safety.<br />
Greg Baumann, Vice President<br />
Technical Services, NPMA<br />
ii
Table of Contents<br />
Introduction.................................................................................................................ii<br />
Definitions...................................................................................................................iv<br />
Section 1: Personnel<br />
1.1 Employee Identification..................................................................................2<br />
1.2 Uniforms...........................................................................................................2<br />
1.3 Security and Criminal Background Checks.....................................................3<br />
1.4 Customer Personnel Practices..........................................................................3<br />
1.5 Vehicles.............................................................................................................4<br />
1.6 Safety................................................................................................................4<br />
1.7 Minimum Training <strong>Standards</strong> for Technicians................................................5<br />
1.8 Compliance with GMPs....................................................................................6<br />
Section 2: <strong>Pest</strong> <strong>Management</strong> Plan<br />
2.1 Rodent Program Exterior Property Survey.....................................................8<br />
2.2 Rodent <strong>Management</strong> Program-Interior Survey..............................................8<br />
2.3 Rodent Program- Facility History....................................................................9<br />
2.4 Rodent Program- Depth Matrix and Frequency of Service............................9<br />
2.5 Rodent Program-Spacing of Stations..............................................................10<br />
2.6 Rodent Program-Monitoring...........................................................................12<br />
2.7 Insect Program.................................................................................................12<br />
2.8 Birds and Wildlife.............................................................................................14<br />
2.9 Weed Control...................................................................................................14<br />
2.10 <strong>Pest</strong> <strong>Management</strong> Survey................................................................................15<br />
2.11 Quality Assurance............................................................................................15<br />
2.12 Annual Training................................................................................................15<br />
2.13 Storage.............................................................................................................16<br />
2.14 <strong>Food</strong> Allergens.................................................................................................16<br />
Section 3: Communications<br />
3.1 Reporting..........................................................................................................18<br />
Section 4: Recordkeeping and Contracts<br />
4.1 Contracts...........................................................................................................20<br />
4.2 Labels and MSDS..............................................................................................20<br />
4.3 <strong>Pest</strong> Sighting Log.............................................................................................20<br />
4.4 Licenses and Certificates..................................................................................20<br />
4.5 Service Protocols and Standard Operating Procedures.................................21<br />
4.6 Service and Treatment Records.......................................................................21<br />
Section 5: <strong>National</strong> Organic Program<br />
5.1 Working in NOP Facilities................................................................................24<br />
Appendix A: Model <strong>Pest</strong> <strong>Management</strong> Inspection Report.......................................26<br />
Appendix B: Current Good Manufacturing Practices (US FDA)...............................27<br />
iii
definitions<br />
<strong>For</strong> definition purposes,<br />
“Company” means the pest management firm<br />
“Contact” means the food plant contact person<br />
“Employee” means pest management firm employee<br />
“Good Manufacturing Practices” means the FDA’s Current Good Manufacturing Practices in the United States, or<br />
equivalent outside of the US.<br />
“<strong>Pest</strong> management product” means any lure, bait, monitoring product, pesticide, or any other formulated<br />
material used in performance of pest management activities.<br />
“Plant” means a food manufacturing facility including associated warehousing and does not include restaurants<br />
or other food service facilities<br />
“Rodent bait station” means any station used for placement of solid rodenticide bait<br />
“Rodent management station” means any station used for monitoring or managing rodents. These include<br />
mechanical traps, rodent bait stations (see above), and other placed equipment for rodent management.<br />
“Technician” means the pest management firm employee providing service<br />
iv
Section 1<br />
Personnel<br />
1
1<br />
SECTION<br />
SECTION 1: PERSONNEL<br />
1.1 Employee Identification<br />
Reasoning<br />
This section sets forth minimum standards for company employee identification so that<br />
the plant has a clear understanding of which personnel are from the pest management<br />
firm to ensure that plant food safety and security are maintained.<br />
Standard<br />
All employees entering grounds of a food plant shall wear photo identification to include:<br />
• employee name<br />
• employee identification number (if issued by the company)<br />
• company name<br />
• company phone number<br />
• employee photo<br />
• date of issue<br />
The identification shall be worn at all times while the employee is on site unless plant<br />
personnel practices set by the customer prohibit such badges. In addition, plants may<br />
require other identification and badges such as visitor badges and the employee must<br />
comply at all times with the visitor/contractor policies of the plant.<br />
1.2 Uniforms<br />
Reasoning<br />
Uniforms are an important part of the plant safety and standards program. Criteria set are<br />
designed to comply with the majority of food plant requirements for uniforms.<br />
Standard<br />
All employees who perform service work in food plants shall wear uniforms meeting the<br />
plant’s current requirements and at least the following criteria:<br />
• Slip Resistant Sole Shoes (steel tips if required by plant)<br />
• Socks<br />
• Long Pants<br />
• Shirt with sleeves (short or long) with company logo or name<br />
• Bump cap if required by the plant<br />
Uniform closures shall be in compliance with plant requirements.<br />
A clean set of clothing shall be used in plants if the previous account visited has exposed<br />
the clothing to contaminants. These contaminants include but are not limited to<br />
chemical, microbiological, or allergens such as peanut products.<br />
More stringent requirements may be in place for individual plants in addition to these<br />
standards and service personnel must comply with those standards.<br />
2
1.3 Security and Criminal Background<br />
Checks<br />
Reasoning<br />
Security is a major concern at all food plants. This section is designed to ensure that<br />
personnel in food plants have had proper background checks and that they comply with<br />
plant rules.<br />
SECTION 1: PERSONNEL<br />
1<br />
SECTION<br />
Standard<br />
Any newly hired employee, including management, entering a food plant shall have a<br />
criminal background check performed covering the previous five years prior to the date<br />
of hire. The checks shall be part of the records of the company and shall include all states<br />
or provinces in which the employee has lived and/or worked during the previous five<br />
years. Resulting action as a result of the check will be at the discretion of the company<br />
management. Some food plants may have specific requirements and companies must<br />
comply with these requirements in addition to the above. Reminder: Companies must<br />
comply with government regulations related to obtaining background checks.<br />
<strong>Plants</strong> may also have policies regarding when an employee is permitted onsite and/or<br />
escorted. Companies should understand and comply with all plant policies and provide a<br />
written procedure to employees with a copy in the plant as to:<br />
• Whether advanced notice must be given prior to arrival onsite<br />
• Parking and vehicle use<br />
• Substitute employees (technicians taking place of previous technicians may have to be<br />
on a roster provided to the plant)<br />
• Sign in policies<br />
• Hours of operation when employees may have access<br />
• Visitor badge policies<br />
• Escort policies<br />
• Restricted areas<br />
1.4 Customer Personnel Practices<br />
Reasoning<br />
It is imperative that all employees entering a food plant property understand and comply<br />
with the plant personnel practices. Besides being required by law, compliance is important<br />
as a part of food safety and also plant personnel morale.<br />
Standard<br />
All employees entering a food plant property must have reviewed and signed off on the<br />
standards of the plant in terms of personnel practices as outlined by the plant. If a special<br />
set of standards is in place for plant contractors, then the employee must comply with<br />
the standards. If any questions or conflicts arise, the employee must either notify their<br />
supervisor or the plant contact person.<br />
A copy of the signed document shall be maintained in the plant files.<br />
3
1<br />
SECTION<br />
SECTION 1: PERSONNEL<br />
1.5 Vehicles<br />
Reasoning<br />
<strong>Plants</strong> have very specific requirements for vehicles both in terms of operations and in<br />
terms of security. This section sets the minimum for vehicle standards.<br />
Standard<br />
All vehicles used for service must:<br />
• Be clearly marked with company name<br />
• Be properly licensed<br />
• Have a current inspection if required by the state or province.<br />
• Have adequate insurance of at least $1 million aggregate bodily injury and property<br />
damage (U.S. and Canada only); for other countries, the minimum insurance required<br />
by law shall be obtained. If plant requires additional insurance, then the plant<br />
requirement must be met<br />
• Be parked in properly assigned area<br />
• Contain materials and equipment secured when unattended to restrict access.<br />
Drivers<br />
A five year motor vehicle background check must be completed for all new company<br />
employees who will drive on plant property.<br />
All drivers must have viewed the NPMA Safe Driving Video or participate in an insurance<br />
industry approved program annually and the company must retain safe driving training<br />
records as required by the insurance company.<br />
In addition, the vehicle must include at least the following equipment:<br />
• First aid kit<br />
• Spill control to cover all products on the vehicle<br />
• Current labels and Material Safety Data Sheets<br />
• Vehicle list (continued):<br />
• Service Kit (carrying kit for small quantities of products and equipment)<br />
• Change of clothing<br />
• Coveralls<br />
• Other equipment required by plant or label of products used in the plant.<br />
1.6 Safety<br />
Background<br />
Safety is a vital part of any pest management program. The pest management company<br />
and the food plant both must maintain safe working environments.<br />
Beyond just minimal regulatory requirements, policies must be in place to ensure a safe<br />
work environment.<br />
Standard<br />
Each company must have a Safety Plan and must document training of all employees<br />
working in food plants. Each company must also provide verification that food plant<br />
specific safety training has been completed. Safety plans must include but are not limited<br />
to:<br />
• Respiratory protection training if a product is used requiring use of a respirator.<br />
Where a respirator is required, respirator training must be completed including the<br />
use of the NPMA Respiratory Safety Video or equivalent. The video is available from<br />
that <strong>National</strong> <strong>Pest</strong> <strong>Management</strong> Association. <strong>For</strong> contact information, visit www.<br />
npmapestworld.org.<br />
4
• <strong>Pest</strong>icide safety including the proper understanding of all labels of products to be<br />
used in the food plant, proper use, and disposal of products and containers<br />
• Proper storage of products and equipment<br />
• Emergency Response in case of spills<br />
• Safety of other personnel near pest management activities such as plant employees<br />
and consumers<br />
• Ladder safety and transportation including tie down<br />
• Use of fall prevention<br />
• Lock out and tag out systems<br />
• Pinch hazards<br />
• Crushing hazards<br />
• Shoe safety<br />
• Personal protective equipment<br />
• Definition of accident<br />
• Reporting requirements including use of OSHA 300 ( www.dol.gov)<br />
• Fumigation plan if fumigation is to be performed (fumigation in general is not<br />
covered by these standards)<br />
• Restricted areas in plant<br />
• Confined space entry requirements<br />
• Hazard communication<br />
SECTION 1: PERSONNEL<br />
1<br />
SECTION<br />
Note: An optional safety manual is available for sale through the NPMA Resource Center<br />
which addresses safety program compliance and will provide guidelines for developing a<br />
safety program. <strong>For</strong> more information go to www.npmapestworld.org.<br />
1.7 Minimum Training <strong>Standards</strong> for<br />
Technicians<br />
Background<br />
Technicians performing pest management in food plants must be properly trained and<br />
verification of training specific to food plants must be shown.<br />
Standard<br />
Any technician performing pest management services in food plants must be trained.<br />
Certain proof of training must be available to the food plant contact.<br />
These standards require pesticide enforcement regulatory agency certification or<br />
registration and verifiable training specific to food plant pest management including<br />
an exam regardless of whether an exam for the state or province has been passed for<br />
certification or registration of technicians.<br />
Testing is conducted via the internet and is administered for a nominal fee by NPMA.<br />
Procedures and verification are the responsibility of NPMA.<br />
NPMA has provided a testing site at www.npmatesting.com. A proctor designated by<br />
the company is required and the test is closed book. Each technician to be tested must<br />
establish his/her own account on the testing site and must select his/her own username<br />
and password. The login information is NOT the company’s NPMA membership login.<br />
There are fifty random questions on the exam and technicians must score 80% (40 correct)<br />
or better to pass. Technicians who do not pass may retake the exam at no additional cost.<br />
An optional study guide is available through the NPMA Resource Center to provide<br />
education on food plant work and to help pass the exam. Not all questions are directly<br />
from the study guide. The testing site does provide advice on how to prepare for the<br />
exam at www.npmatesting.com.<br />
5
1<br />
SECTION<br />
SECTION 1: PERSONNEL<br />
1.8 Compliance with GMPs<br />
Background<br />
Federal agencies have established regulations to include basic food safety. This<br />
requirement is to ensure compliance with US Current Good Manufacturing Practices or<br />
equivalent in other countries.<br />
Standard<br />
All pest management programs must comply with Current Good Manufacturing Practices<br />
(GMPs). All technicians performing any type of work in food plants must be trained in<br />
requirements of GMPs and plant implementation. Also plants may have GMP-related<br />
requirements beyond GMPs and technicians must be trained in plant policies as well.<br />
Written verification must be on file in the plant and in the company office.<br />
6
Section 2<br />
<strong>Pest</strong> <strong>Management</strong> Plan<br />
7
SECTION 2: PEST MANAGEMENT PLAN<br />
2.1 Rodent Program-Exterior Property<br />
Survey<br />
2<br />
SECTION<br />
Prior to developing a rodent management program at each plant site, a thorough<br />
inspection must be made of the entire property. The property should be inspected and<br />
the following observations at a minimum must be identified and documented using a<br />
diagram and/or notes:<br />
• Areas of rodent infestation based upon sightings, harborages, or other evidence<br />
including all areas of the building including roofs<br />
• Areas conducive to infestation of the property such as cluttered areas, open trash,<br />
standing water, potential or confirmed burrowing areas<br />
• Dumpsters which are not on rigid cleanable areas such as concrete pads<br />
• Open doors or gaps in building areas which could permit rodent entry<br />
• Clutter or debris underneath load levelers<br />
• Dock areas that have clutter or debris<br />
• Off loading areas with clutter or debris<br />
• Tall grass and vegetation on property, sidings, and adjacent to buildings<br />
• Perimeter areas of buildings having less than 24” of clearance and areas not having<br />
gravel or other material which will reduce chances of rodent activity<br />
• Neighboring properties which may have conditions leading to infestation<br />
A summary of infestation observations and potential infestation must be documented and<br />
presented to the pest management contact of the plant.<br />
2.2 Rodent <strong>Management</strong> Plan-Interior<br />
Survey<br />
All areas of the plant interior shall be surveyed for rodents and conditions which may lead<br />
to rodent infestation. These areas shall include but are not limited to:<br />
• Pallet storage<br />
• Warehouse<br />
• Incoming raw materials<br />
• Packaging storage<br />
• Processing<br />
• Finished goods storage<br />
• Returned goods area<br />
• Waste disposal<br />
• Workshop<br />
• Sanitation area<br />
• Offices areas<br />
• Other areas<br />
Any rodent management devices shall be mapped and recorded.<br />
8
SECTION 2: PEST MANAGEMENT PLAN<br />
2.3 Rodent Program-Facility History<br />
Prior to designing and implementing a rodent management program, a company<br />
representative shall interview plant contacts and review all available rodent history<br />
information. This will help develop an effective rodent management plan.<br />
In the course of the inspection, maintenance issues such as but not limited to holes<br />
in walls, pipe chases, bulk feed lines, spilled food items, or open doors/windows shall<br />
be noted. Recommendations shall be made to the plant to reduce chances of future<br />
infestation.<br />
<strong>For</strong>m NPMA-38 (Appendix A) may be used. As requested by members, optional supplies of<br />
pre-printed NPMA-38 forms in carbonless copy format are available for sale through the<br />
NPMA Resource Center.<br />
2<br />
SECTION<br />
2.4 Rodent Program-Depth Matrix &<br />
Frequency of Service<br />
As a result of an initial inspection, examination of history, and discussions with plant<br />
personnel, the level of rodent management program area can be developed. This is<br />
history versus the potential. If the plant is totally sealed, and there is minimal chance<br />
of infestation by rodents, then the potential is reduced. If there is ample raw material<br />
exposed, or open doors on the building exterior, then the potential is much higher.<br />
<strong>For</strong> history:<br />
• Category 3 denotes no significant evidence or history in the building in the past year;<br />
• Category 2 denotes no significant evidence or history in the past six months;<br />
• Category 1 denotes significant evidence or history in the past six months. The<br />
following Matrix can determine the level of the management program necessary. The<br />
category assignment of 1 is most intense.<br />
<strong>For</strong> Potential:<br />
Potential is determined by plant maintenance such as holes, unsealed pipe chases, etc.,<br />
and operations such as open doors, at grade loading docks, etc., and surrounding rodent<br />
pressure<br />
• Category 3 denotes no significant potential for infestation due to plant maintenance<br />
and operations, and rodent pressure<br />
• Category 2 denotes medium potential for infestation due to plant maintenance and<br />
operations, and rodent pressure<br />
• Category 1 denotes high potential for infestation due to plant maintenance and<br />
operations, and rodent pressure<br />
9
SECTION 2: PEST MANAGEMENT PLAN<br />
RODENT MANAGEMENT EXTERIOR PROGRAM-DEPTH MATRIX<br />
Potential and History: Potential for Infestation (One is most intense, two is medium,<br />
and three is least intense)<br />
2<br />
Intensity Increases from 3 to 1<br />
History<br />
SECTION<br />
Potential<br />
3<br />
2<br />
3 2 1<br />
6 5 4<br />
5 4 3<br />
1<br />
4 3 2<br />
The Potential score based upon the above criteria must be determined by and is at<br />
the sole discretion of the pest management company. The history score must also be<br />
determined as previously noted. They are then added together to get a matrix score,<br />
which is the italicized score on the matrix.<br />
FREQUENCY OF SERVICE, EXTERIOR AREAS<br />
<strong>For</strong> exterior of buildings: If the score is 2, 3, or 4, then the exterior service interval<br />
must be at least twice monthly. If the score is 5 or 6, the exterior service may be monthly.<br />
Results of the analysis and conclusions should be reviewed by and accepted by plant<br />
contact and may be reviewed and adjusted as necessary.<br />
2.5 Rodent Program-Spacing of Rodent<br />
<strong>Management</strong> Stations<br />
SPACING OF RODENT MANAGEMENT STATIONS<br />
Special note for 2009: There is a trend towards needs-based placement of stations,<br />
either mechanical, bait, monitoring, or other devices, rather than assigning specific<br />
spacing. NPMA supports science based rodent management plans. When these <strong>Standards</strong><br />
were conceived, many third party auditors required stations based solely upon spacing<br />
regardless of pest pressures. The Spacing of Stations section is an interim step between<br />
arbitrary placement without justification and implementing rodent management<br />
programs based upon real need supported by scientific evidence. This section will be<br />
modified when the scientific research leads the industry to the new philosophy of rodent<br />
management. NPMA will continue to monitor developments in rodent management in<br />
anticipation of shifting towards this new philosophy when it is ready for industry-wide<br />
adoption.<br />
Note: any placement should be approved by plant contact to make sure that the program<br />
complies with plant corporate policies<br />
Record of service verification such as stickers, cards, or bar codes shall be on the inside of<br />
the station, requiring the station to be opened to record data or to scan.<br />
10
SECTION 2: PEST MANAGEMENT PLAN<br />
Proper care must be exercised to comply with the label in terms of access to children or<br />
non-target animals. If it is not possible to install stations in secure areas then glue boards<br />
or snap traps or other mechanical traps may be used inside of locked and anchored<br />
stations.<br />
Monitoring stations may be used at any interval with a non-toxic block.<br />
EXTERIOR PERIMETER<br />
Property Perimeter: If an exterior property perimeter program is utilized, then based<br />
upon history only, rodent management equipment, such as but not limited to rodent bait<br />
stations or multiple-catch traps, shall be placed along property perimeter areas (e.g. fence<br />
lines or outer boundaries) at the rate of:<br />
• <strong>For</strong> History Category 1: Spacing of not more than 50 feet<br />
• <strong>For</strong> History Category 2: Spacing of 50-75 feet<br />
• <strong>For</strong> History Category 3: Spacing of up to 100 feet<br />
2<br />
SECTION<br />
Exterior Building Areas (buildings at or near exterior walls of buildings on plant property)<br />
Based upon history, rodent bait stations shall be placed along building exterior areas at<br />
the rate of:<br />
• <strong>For</strong> History Category 1: Spacing of not more than 25 feet<br />
• <strong>For</strong> History Category 2: Spacing of between 25-50 feet<br />
• <strong>For</strong> History Category 3: Spacing of up to 75 feet<br />
Rodent management devices should be added adjacent to doors, docks, and ramps to the<br />
level of History Category 1 at least but may be placed adjacent to any exterior opening<br />
per company practices.<br />
INTERIOR OF PLANT<br />
The inside of any exterior wall should have multiple-catch traps or glueboards in stations<br />
at the rate of one per 20-40 feet. In areas of high traffic, stations should be placed directly<br />
against the wall and should be protected or covered if necessary to prevent forklift<br />
damage. Interior traps do not have to be anchored. Traps may be placed along interior<br />
walls at the discretion of the pest management company. Interior rodent management<br />
programs shall be monitored weekly.<br />
Multiple-catch traps may be supplemented at a rate determined by the technician with<br />
snap traps in stations or glue boards added into PVC pipes. These traps may be used also<br />
on mezzanines where equipment is stored and in areas where using large traps may be<br />
cumbersome, such as in areas of heavy activity and dense storage areas. All stations must<br />
be recorded and numbered and records must reflect the placement.<br />
Rodenticides shall not be used inside food plants in any area unless approved by the plant<br />
contact and permitted by label. Upon such a request, any action and reasoning must be<br />
documented and should be temporarily used when there is no exposed food product.<br />
Non-toxic monitoring blocks may be used if permitted by plant contact.<br />
<strong>Plants</strong> should have an inspection aisle of at least 18 inches along walls. Commonly, this<br />
area is painted white in order to contrast with droppings or insects. Traps may be placed<br />
along these areas.<br />
Due to concerns about allergens, no peanut butter or nut based attractants may be used<br />
inside a plant unless approved by plant contact.<br />
11
SECTION 2: PEST MANAGEMENT PLAN<br />
2.6 Rodent Program-Monitoring<br />
2<br />
SECTION<br />
Adjustments to the program based upon observations may be made at any time. Use of<br />
“temporary” program changes are acceptable. All traps, bait stations, and other devices<br />
must be opened and inspected. Record of service verification or bar code shall be on the<br />
inside of the station requiring the station to be opened. Observations must be recorded as<br />
outlined in the Recordkeeping section.<br />
A master map of all rodent control devices used on the property must be maintained and<br />
kept current.<br />
Rodents must be disposed of in a sanitary method offsite per company policy. Rodents,<br />
droppings, and any urine deposits or residue must be handled using protective gear per<br />
company policy.<br />
2.7 Insect Program<br />
Inspection<br />
A thorough inspection shall be conducted of the exterior of the building including<br />
raw material receiving, receiving docks, shipping docks, load levelers, waste disposal,<br />
entrances, roof areas, exterior storage such as silos, doors and windows, and ventilation<br />
intakes to investigate signs of infestation or possible signs of infestation by stored product<br />
insects.<br />
A thorough inspection of the accessible components of the plant shall be conducted<br />
not less than monthly. The areas to be inspected includes but is not limited to floor/wall<br />
junctures, drop ceilings, equipment, processing areas, warehousing materials and racking,<br />
offices, locker rooms, mezzanines, raw material handling and processing, returned goods<br />
areas, sample areas, windows, ventilation, shop areas, packaging storage and equipment,<br />
laboratory areas, and cafeteria. See 2.10 for documentation.<br />
In the course of the inspection, maintenance issues such as but not limited to holes<br />
in walls, pipe chases, bulk feed lines, spilled food items, or open doors/windows shall<br />
be noted. Recommendations shall be made to the plant to reduce chances of future<br />
infestation.<br />
Stored Product Insects<br />
Determination of the source of stored product pests must be completed prior to action.<br />
Sometimes, a certain lot of raw materials can be isolated as the source. If pests have<br />
spread into the plant, management measures must be performed.<br />
Pheromones and pheromone traps may be used as part of the monitoring and<br />
management processes.<br />
Non-Stored Product Insects and Occasional Invaders<br />
Determination of source and entry point, real or potential, is necessary in developing a<br />
control/management program. Commonly, mechanical alterations on the exterior will<br />
be necessary such as filtering incoming air, sealing cracks, repairing door gaskets or self<br />
closing doors, etc.<br />
Prevention and <strong>Management</strong> of Insects<br />
Insects shall be managed using a product labeled for the site. These products may be<br />
residual or non-residual products.<br />
12
SECTION 2: PEST MANAGEMENT PLAN<br />
Non-regulated/exempt products (including but not limited to essential oil products,<br />
limestone dusts, etc.) may be used according to the instructions and in a crack and crevice<br />
or spot method only.<br />
Space treatment may be used to reduce adult populations. This may also include the use<br />
of insect growth regulators (IGRs).<br />
General applications may be used only if the use of the product will not contaminate the<br />
food product.<br />
<strong>Pest</strong>s may also be managed by fumigation after coordination with the plant contact.<br />
These standards do not address fumigation specifically.<br />
Insect bait stations may be used in areas not prone to heavy traffic or water accumulation.<br />
2<br />
SECTION<br />
Treatment of electrical panels and boxes must be done with extreme care per the label<br />
and liquids should not be used.<br />
Insect Light Traps and Flying Insect Traps<br />
Insect light traps (ILTs) may be installed to monitor and manage certain flying insects and<br />
to be used in the decision making process for adjusting the program for certain insects<br />
(e.g. Indianmeal moths, fruit flies, etc.). Findings and seasonal requirements will dictate<br />
frequency of inspection. Placement must be according to manufacturer’s instructions and<br />
in compliance with any regulatory policies and guidelines. In absence of instructions, ILTs<br />
should be placed where plant operations will not interfere with the operation. Typically,<br />
ILTs should be placed not less than two feet but not more than five feet above floor level<br />
unless specified by manufacturer instructions or due to special circumstances such as<br />
targeting high flying insects. Any ILT must be recorded on the site layout or map and ILTs<br />
must have the same recordkeeping as other types of traps.<br />
ILTs must be monitored based upon the contract and weekly monitoring is suggested for<br />
most cases unless the traps are in an area or at a time of year when there is no activity<br />
(e.g. unheated warehouse in winter in colder climates). The tray must be emptied. Insects<br />
in the tray must be examined and categorized according to:<br />
• stored product insects<br />
• flies<br />
• occasional invaders<br />
The technician should determine if the types and numbers of insects reveal a concern and<br />
if so, then the insect management program should be modified to address the issue.<br />
Bulbs in ILTs must be changed according to manufacturer’s recommendations but in any<br />
case at least annually. Shatter protection must be in place where food or packaging may<br />
become contaminated by glass.<br />
Sticky type ILTs must be monitored at least monthly and the sticky board must be replaced<br />
if ineffective. Type of insects on the board must be recorded and categorized according to<br />
above.<br />
Sticky type traps including pheromone sticky traps or other flying insect traps must be<br />
monitored at least monthly and the sticky material must be replaced at ineffective. Type<br />
of insects on the board must be recorded and categorized according to above.<br />
The insect program must be reviewed with the plant contact at least annually and<br />
adjustments must be made as necessary. Any services may not contaminate nor potentially<br />
contaminate food, food contact surfaces, or food packaging.<br />
13
SECTION 2: PEST MANAGEMENT PLAN<br />
2.8 Birds and Wildlife<br />
Birds and wildlife can enter plants or plant areas and create contamination or potential<br />
contamination hazards.<br />
2<br />
SECTION<br />
In the course of the inspection, maintenance issues such as but not limited to holes<br />
in walls, pipe chases, bulk feed lines, spilled food items, or open doors/windows shall<br />
be noted. Recommendations shall be made to the plant to reduce chances of future<br />
infestation.<br />
Bird Prevention/<strong>Management</strong><br />
Areas susceptible to infestation by birds shall be called to the attention of the plant<br />
contact. If the plant approves, bird prevention measures may be installed. These shall be<br />
any type of wire, net, device, or material to prevent roosting.<br />
No restricted use pesticides designed for scaring of birds may be used inside any structure<br />
where food is exposed. Any such product use shall be in areas inaccessible to non-target<br />
species and plant personnel.<br />
Any interior bird removal shall be by trapping and removal in accordance with<br />
regulations. Exterior infestations such as geese on grounds may be managed by scaring<br />
devices or repellents. Use must be in accordance with manufacturer’s instructions. Use of<br />
protective gear shall be required for removal of nests and/or droppings<br />
<strong>Plants</strong> should be encouraged to eliminate favorable conditions for bird infestation and<br />
observations by the technician shall be recorded in the log.<br />
Within the confines of the above, additional information on bird management may be<br />
found in the NPMA <strong>Pest</strong> <strong>Management</strong> Library, available through the NPMA Resource<br />
Center (www.npmapestworld.org).<br />
Wildlife Prevention/<strong>Management</strong><br />
Areas susceptible to infestation by wildlife shall be called to the attention of the plant<br />
contact. If the plant approves, wildlife prevention measures may be installed. These shall<br />
be any type of wire, net, device, or material to prevent entry, nesting, and/or roosting.<br />
This is usually beyond the scope of the original contract and a separate contract should be<br />
developed.<br />
Any miscellaneous animal removal shall be by trapping and removal in accordance<br />
with local regulations. Exterior infestations such as prairie dogs on grounds may be<br />
managed by repellents or other method according to label or instructions. Use must be in<br />
accordance with manufacturer’s instructions.<br />
<strong>Plants</strong> should be encouraged to eliminate favorable conditions for wildlife infestation and<br />
observations by the technician shall be recorded in the log.<br />
Within the confines of the above, additional information on wildlife biology and<br />
management may be found in the NPMA <strong>Pest</strong> <strong>Management</strong> Library.<br />
2.9 Weed <strong>Management</strong><br />
Vegetation should not be planted against the buildings (exterior). An inspection band and<br />
clear zone adjacent to the building should be encouraged as part of the periodic audit. If<br />
the company performs weed management, ideally a vegetation free clear zone should be<br />
maintained.<br />
This item shall be checked as part of the normal audit process during pest management<br />
service regardless of whether the company performs weed management. Any<br />
14
SECTION 2: PEST MANAGEMENT PLAN<br />
vegetation around the building should be called to the attention of the plant contact<br />
for management in order to reduce the chances of infestation. Note: Certain types of<br />
vegetation/plantings may be more susceptible to pest harborage. These may be noted<br />
during the audit.<br />
2.10 <strong>Pest</strong> <strong>Management</strong> Survey<br />
At least monthly, the pest management company shall perform a survey to look at<br />
infestation by pests and the potential for infestation. Building maintenance, employee<br />
practices, physical conditions of the plant, incoming materials, processing, and shipping<br />
shall be evaluated. Recommendations shall be presented to the plant contact including<br />
results of plant documents such as incoming materials inspection and pest sightings, and<br />
technician observations.<br />
2<br />
SECTION<br />
The NPMA form NPMA 38 or equivalent shall be used to record observations and<br />
recommendations and a copy shall be disclosed to and signed by the plant contact.<br />
All NPMA 38 or equivalent forms shall have one copy submitted to plant contact, one<br />
copy shall be filed with the pest management records and a copy shall be kept by the pest<br />
management firm unless the forms are filed and maintained electronically.<br />
2.11 Quality Assurance<br />
At least once per year, prior to the anniversary of the date on which the company began<br />
pest management services at the food plant, a supervisor, quality assurance staff person,<br />
or a manager from the pest management company shall review the entire program<br />
onsite. The QA audit shall look at the program, records, and frequency, as well as the<br />
monthly audits to make sure that all documentation is in order. In addition, labels and<br />
MSDS must be reviewed to make sure that all products used have current information.<br />
MSDS and labels of pest management products used at that facility must be filed either in<br />
hard copy or via electronic records.<br />
Results of the quality assurance audit must be filed in the plant, with a copy in the pest<br />
management company office.<br />
2.12 Annual Training<br />
At least once per year, the pest management company shall offer to conduct an<br />
educational program for plant personnel. Date, content, and list of those who attend<br />
must be kept in the plant pest management records.<br />
The following staff should be encouraged to participate:<br />
• <strong>Management</strong><br />
• Supervisory staff<br />
• Security<br />
• Mechanics<br />
• Production lead staff<br />
• Warehousing staff<br />
• Quality Assurance staff<br />
• Plant contact<br />
• HACCP committee, if applicable<br />
• Others determined by the plant management<br />
15
SECTION 2: PEST MANAGEMENT PLAN<br />
2<br />
SECTION<br />
While the plant ultimately makes the decision as to who may attend, the content shall<br />
include:<br />
• Review of the pest management program<br />
• Product flow<br />
• Vulnerable areas<br />
• Practices which may reduce pest pressures<br />
• Review of audits and monthly reports<br />
• How to record a pest sighting<br />
Review of FDA, state, provincial, local, and third party audits and inspections as related to<br />
pest management.<br />
How plant personnel should interact with pest management tools and devices<br />
2.13 Storage<br />
All pesticides for use in pest management shall be stored off site or in a locked and<br />
secured storage area with adequate spill control and safety equipment for all materials<br />
stored. All storage must be in compliance with government regulations as well as the<br />
policies of the food plant. Any storage requirements listed on the label must also be<br />
addressed. If storage is in a locked cabinet, all room requirements must be met. Fumigants<br />
shall not be stored onsite unless storage requirements of the label are met.<br />
Records must be stored in a secured area.<br />
2.14 Compliance with Plant <strong>Food</strong> Allergen<br />
Control Program<br />
Background<br />
In recent years, there has been a great emphasis on food allergens, most<br />
notably, peanut products. Many consumers have acute reactions to food<br />
allergens. “Big Eight” allergens include: cow’s milk, eggs, peanuts, tree nuts,<br />
soybean products, wheat, fish, and crustacean shellfish. Consequently, food<br />
plants must declare if there is a possibility of any of these products entering the<br />
food either as an ingredient or an incidental additive. Plant policies and third party<br />
auditor standards may require formal food allergen control programs and these might<br />
affect pest management practices.<br />
Standard<br />
The pest management company must comply with any plant food allergen control<br />
program as it relates to pest management practices.<br />
16
Section 3<br />
Communication<br />
17
SECTION 3: COMMUNICATION<br />
3.1 Reporting<br />
All records and documents may be retained electronically.<br />
All documents in the pest management filing system must be available to the plant<br />
within a reasonable time as determined by the plant. The plant has the option of<br />
requesting copies of all documents produced including service tickets for their files.<br />
The pest management company must keep a backup copy of all documents at the pest<br />
management company office. The pest management company shall not surrender any<br />
copies of materials to any official without the express written permission of the plant<br />
contact or their substitute. If there is a regulatory audit of the pest management such<br />
as the state department of agriculture or other pesticide enforcement agency, the pest<br />
management company may surrender documents to the agency if required.<br />
3<br />
SECTION<br />
While paper backup information may be permitted, official documentation and reporting<br />
listed in these standards shall be retained in the following manner:<br />
Reporting shall provide access to all service data<br />
Record recovery shall be available on demand with the ability to be sorted by product<br />
used, area, pest, date, time, and shift.<br />
Trends shall be determined at the interval of service.<br />
Data onsite may be gathered by handheld electronic devices or manually or a combination<br />
of these methods<br />
Trends may be used to modify the pest management program based upon observations.<br />
All inspections reports such as, but not limited to the NPMA 38, may be available online<br />
18
Section 4<br />
Recordkeeping and Contracts<br />
19
SECTION 4: RECORDKEEPING AND CONTRACTS<br />
4.1 Contracts<br />
Prior to completing any work in a food plant, a signed contract must be in place unless<br />
specifically waived by the food plant and must include:<br />
• Name of Plant<br />
• Plant contact person<br />
• Frequency of visits<br />
• Description of services<br />
• Term of contract<br />
• Fee<br />
• Equipment storage and product storage specifications<br />
• Scope of emergency calls<br />
• Products which may be used<br />
• Service records to be issued to the plant<br />
• Requirement to notify plant of any new products used<br />
4.2 Labels and MSDS<br />
4<br />
SECTION<br />
A copy of all EPA, PMRA (Canadian <strong>Pest</strong> <strong>Management</strong> Regulatory Authority), or other<br />
country product labels and Material Safety Data Sheets for pest management products<br />
used at the plant shall be maintained in the plant by the pest management company. Only<br />
labels and MSDS for products which may be used at the plant should be included in the<br />
“active” file. This may also be filed electronically or web-based. A label and MSDS shall be<br />
added for any new products used.<br />
4.3 <strong>Pest</strong> Sighting Log<br />
Each pest management company shall provide a <strong>Pest</strong> Sighting Log to be maintained in a<br />
plant office which may be the pest management area. The log shall include dates, times,<br />
locations, type of pest, action taken, and name of reporting employee. The log shall be<br />
reviewed by the technician at each visit and data shall be included in adjusting the pest<br />
management program as necessary. At the periodic training by the pest management<br />
company, the use of the log shall be discussed.<br />
4.4 Licenses and Certificates<br />
Credentials to be maintained at the plant with the pest management records must<br />
include:<br />
• Copy of the certification or registration document, if issued in the plant jurisdiction,<br />
for each person who will perform pest management services in the plant<br />
• Copy of the pest management company license to operate issued by the state or<br />
provincial lead pesticide enforcement agency if issued by the state or province in the<br />
jurisdiction.<br />
• Copy of the insurance certificate<br />
• Copy of proof of successful completion of verifiable training and exam for each<br />
technician servicing the plant.<br />
20
SECTION 4: RECORDKEEPING AND CONTRACTS<br />
4.5 Service Protocols and Standard<br />
Operating Procedures<br />
Standard Operating Procedures shall be developed in partnership between the pest<br />
management company and the food plant. All scope of work information including<br />
methods of inspection and treatment must be documented and approved by the food<br />
plant. Protocols and procedures shall include at least the following:<br />
• Procedures for all current or anticipated pest management activities including<br />
inspections and audits<br />
• <strong>Pest</strong> sighting log<br />
• <strong>Pest</strong> activity records<br />
• Treatment Records (see 4.6 for minimum information required)<br />
• Trend reports<br />
• Plant layout with pest management activity information listed such as rodent stations,<br />
monitoring devices, etc.<br />
4.6 Service and Treatment Records<br />
All service records for service including applications and/or monitoring shall include:<br />
• EPA or PMRA registration number<br />
• Product brand name<br />
• Target pest<br />
• Rate of application or % concentration<br />
• Time of application<br />
• Location or site of application<br />
• Amount of finished product used<br />
• Date<br />
• Lot number of product<br />
• Signature of technician<br />
• Signature of plant contact<br />
• Certification or registration number of technician<br />
• Emergency phone number<br />
• Notes and observations and any other records required by the state pest management<br />
enforcement agency<br />
4<br />
SECTION<br />
21
Section 5<br />
<strong>National</strong> Organic Program<br />
23
SECTION 5: NATIONAL ORGANIC PROGRAM (NOP)<br />
5.1 Working in NOP Facilities<br />
The USDA <strong>National</strong> Organic Program is governed by Rule 205.271 and requires the<br />
handler or management of the organic facility to use management practices to prevent<br />
pests. While many of the physical prevention methods are beyond the scope of the pest<br />
management company, the NOP records will work with the pest management program<br />
to ensure that there is compliance with Rule 205.271. The NOP does not prevent the<br />
use of pest management methods or products; however, the NOP does require that<br />
pest prevention is done through mechanical or physical management and/or natural or<br />
approved traps and repellents. If these measures fail to manage the pests, the facility may<br />
use a natural substance approved by the organic certifying body, and if that fails, then<br />
a synthetic substance may be used “provided that the handler and the certifying agent<br />
agree on the substance, method of application, and measures to be taken to prevent<br />
contact of the organically produced products or ingredients with the substance used.”<br />
The NOP requires full attention to IPM. The plant will have specialized rules governing<br />
pest management activities in the plant.<br />
In addition to the standards in sections one through four, the NOP facilities will require<br />
the Standard Operating Procedures (SOPs) to prioritize pest management methods based<br />
on the information above. The company shall work with the facility to make sure that the<br />
procedures and SOPs comply with the plant SOPs regarding pest management. See federal<br />
government publications for more information.<br />
Note: some organic facilities are audited by a certification group which may have<br />
approved methods or products.The plant should be consulted as to special requirements.<br />
Procedures to ensure that the food will not be contaminated by any pest management<br />
method must be in place prior to beginning any service.<br />
5<br />
SECTION<br />
24
Appendices<br />
25
APPENDIX A: Model <strong>Pest</strong> <strong>Management</strong> Inspection Report<br />
Inspector: ___________________________________________________________________________ Date: _______________<br />
1. No evidence of pest activity<br />
2. No pest harborage areas<br />
3. Adequate trash handling<br />
4. Proper trash containers<br />
5. All trash contained<br />
6. Proper storage of waste paper and cardboard<br />
7. Pavement areas in good repair and properly drained<br />
8. Adequate weed management adjacent to building<br />
9. Adequate exterior rodent management program<br />
10. Adequate exterior insect management program<br />
11. No evidence of bird roosting<br />
12. Sufficient cleaning capabilities to prevent buildup of food which may attract pests (e.g. flour spills<br />
at railroad offloading, corn syrup spills from trucks, etc.)<br />
13. No evidence of plumbing or sewer leaks<br />
14. Screens and vents clean<br />
15. Open doors and windows screened<br />
16. Visible condensate lines clear and clean<br />
A<br />
APPENDIX<br />
Interior Areas<br />
1. Walls: Clean, proper materials, and in good repair<br />
2. Floors: Clean, proper materials, and in good repair<br />
3. Ceilings: Clean, proper materials, and in good repair<br />
4. Elevator pits clean and dry<br />
5. Floor drains clean with secured covers<br />
6. Plumbing in good repair as related to pest potential<br />
7. Visible condensate lines clear and no pooling of condensate<br />
8. Other maintenance issues<br />
9. No evidence of pest activity<br />
10. Inspection aisles properly maintained<br />
11. Other practices issues<br />
12. Packaging material properly stored<br />
13. Containers properly stored and clean<br />
14. Damaged/returned good isolated<br />
15. Equipment clean and pest free<br />
16. Maintenance areas clean and no evidence of pests<br />
17. Sanitation area clean and no evidence of pests; mops and tools stored off floor<br />
18. Compliance with pest portion of GMPs<br />
19. <strong>Pest</strong> management equipment clean and maintained (e.g. light traps, etc.)<br />
Exterior Areas (including roof areas) OK Corrections Required N/A<br />
Technician: __________________________________________________________________________ Date: _______________<br />
Comments: _______________________________________________________________________________________________<br />
Signature of Technician: ___________________________________________________________________________________<br />
26
Appendix B: <strong>Food</strong> and Drug Administration, HHS § 110.3<br />
Subpart D — Naturally Occurring Poisonous or Deleterious Substances<br />
[Reserved]<br />
PART 110 — CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING,<br />
PACKING, OR HOLDING HUMAN FOOD — Table of Contents<br />
Subpart A — General Provisions<br />
Sec. 110.3 Definitions.<br />
110.5 Current good manufacturing practice.<br />
110.10 Personnel.<br />
110.19 Exclusions.<br />
Subpart B — Buildings and Facilities<br />
110.20 Plant and grounds.<br />
110.35 Sanitary operations.<br />
110.37 Sanitary facilities and controls.<br />
Subpart C — Equipment<br />
110.40 Equipment and utensils.<br />
Subpart B [Reserved]<br />
Subpart E — Production and Process Controls<br />
110.80 Process and controls.<br />
110.93 Warehousing and distribution<br />
Subpart F [Reserved]<br />
Subpart G — Defect Action Levels<br />
110.110 Natural or unavoidable defects in food for human use that present no health<br />
hazard.<br />
AUTHORITY: 21 U.S.C. 342, 371, 374; 42 U.S.C. 264<br />
SOURCE: 51 FR 24475, June 19, 1986, unless otherwise noted.<br />
Subpart A — General Provisions<br />
§ 110.3 Definitions.<br />
The definitions and interpretations of terms in section 201 of the Federal <strong>Food</strong>, Drug,<br />
and Cosmetic Act (the act) are applicable to such terms when used in this part. The following<br />
definitions shall also apply:<br />
(a) Acid foods or acidified foods means foods that have an equilibrium pH of 4.6 or<br />
below.<br />
(b) Adequate means that which is needed to accomplish the intended purpose in keeping<br />
with good public health practice.<br />
(c) Batter means a semifluid substance, usually composed of flour and other ingredients,<br />
into which principal components of food are dipped or with which they are coated,<br />
or which may be used directly to form bakery foods.<br />
(d) Blanching, except for tree nuts and peanuts, means a prepackaging heat treatment<br />
of foodstuffs for a sufficient time and at a sufficient temperature to partially or completely<br />
inactivate the naturally occurring enzymes and to effect other physical or biochemical<br />
changes in the food.<br />
(e) Critical control point means a point in a food process where there is a high probability<br />
that improper control may cause, allow, or contribute to a hazard or to filth in the<br />
final food or decomposition of the final food.<br />
(f) <strong>Food</strong> means food as defined in section 201(f) of the act and includes raw materials<br />
and ingredients.<br />
(g) <strong>Food</strong>-contact surfaces are those surfaces that contact human food and those surfaces<br />
from which drainage onto the food or onto surfaces that contact the food ordinarily<br />
occurs during the normal course of operations. ``<strong>Food</strong>-contact surfaces’’ includes utensils<br />
and food-contact surfaces of equipment.<br />
B<br />
APPENDIX<br />
27
Appendix B: <strong>Food</strong> and Drug Administration, HHS § 110.3<br />
(h) Lot means the food produced during a period of time indicated by<br />
a specific code.<br />
(i) Microorganisms means yeasts, molds, bacteria, and viruses and includes, but is not<br />
limited to, species having public health significance. The term ``undesirable microorganisms’’<br />
includes those microorganisms that are of public health significance, that subject<br />
food to decomposition, that indicate that food is contaminated with filth, or that otherwise<br />
may cause food to be adulterated within the meaning of the act. Occasionally in<br />
these regulations, FDA used the adjective ``microbial’’ instead of using an adjectival phrase<br />
containing the word microorganism.<br />
(j) <strong>Pest</strong> refers to any objectionable animals or insects including, but not limited to, birds,<br />
rodents, flies, and larvae.<br />
21 CFR Ch. 1 (4-1-101 Edition) § 110.5<br />
(k) Plant means the building or facility or parts thereof, used for or in connection with<br />
the manufacturing, packaging, labeling, or holding of human food.<br />
(l) Quality control operation means a planned and systematic procedure for taking all<br />
actions necessary to prevent food from being adulterated within the meaning of the act.<br />
(m) Rework means clean, unadulterated food that has been removed from processing<br />
for reasons other than insanitary conditions or that has been successfully reconditioned by<br />
reprocessing and that is suitable for use as food.<br />
(n) Safe-moisture level is a level of moisture low enough to prevent the growth of<br />
undesirable microorganisms in the finished product under the intended conditions of<br />
manufacturing, storage, and distribution. The maximum safe moisture level for a food is<br />
based on its water activity (aw). An aw will be considered safe for a food if adequate data<br />
are available that demonstrate that the food at or below the given aw will not support<br />
the growth of undesirable microorganisms.<br />
(o) Sanitize means to adequately treat food-contact surfaces by a process that is effective<br />
in destroying vegetative cells of microorganisms of public health significance, and in<br />
substantially reducing numbers of other undesirable microorganisms, but without adversely<br />
affecting the product or its safety for the consumer.<br />
(p) Shall is used to state mandatory requirements.<br />
(q) Should is used to state recommended or advisory procedures or identify recommended<br />
equipment.<br />
(r) Water activity (aw) is a measure of the free moisture in a food and is the quotient of<br />
the water vapor pressure of the substance divided by the vapor pressure of pure water at<br />
the same temperature.<br />
B<br />
APPENDIX<br />
§ 110.5 Current good manufacturing practice<br />
(a) The criteria and definitions in this part shall apply in determining whether a food<br />
is adulterated (1) within the meaning of section 402(a)(3) of the act in that the food<br />
has been manufactured under such conditions that it is unfit for food; or (2) within the<br />
meaning of section 402(a)(4) of the act in that the food has been prepared, packed, or<br />
held under insanitary conditions whereby it may have become contaminated with filth, or<br />
whereby it may have been rendered injurious to health. The criteria and definitions in this<br />
part also apply in determining whether a food is in violation of section 361 of the Public<br />
Health Service Act (42 U.S.C. 264).<br />
(b) <strong>Food</strong> covered by specific current good manufacturing practice regulations also is<br />
subject to the requirements of those regulations.<br />
§ 110.10 Personnel<br />
The plant management shall take all reasonable measures and precautions to ensure<br />
the following:<br />
(a) Disease control. Any person who, by medical examination or supervisory observation,<br />
is shown to have, or appears to have, an illness, open lesion, including boils, sores,<br />
or infected wounds, or any other abnormal source of microbial contamination by which<br />
there is a reasonable possibility of food, food-contact surfaces, or food-packaging materials<br />
becoming contaminated, shall be excluded from any operations which may be expected<br />
to result in such contamination until the condition is corrected. Personnel shall be<br />
instructed to report such health conditions to their supervisors.<br />
28
Appendix B: <strong>Food</strong> and Drug Administration, HHS § 110.3<br />
(b) Cleanliness. All persons working in direct contact with food, food-contact surfaces,<br />
and food-packaging materials shall conform to hygienic practices while on duty to the<br />
extent necessary to protect against contamination of food. The methods for maintaining<br />
cleanliness include, but are not limited to:<br />
(1) Wearing outer garments suitable to the operation in a manner that protects against<br />
the contamination of food, food-contact surfaces, or food-packaging materials.<br />
(2) Maintaining adequate personal cleanliness.<br />
(3) Washing hands thoroughly (and sanitizing if necessary to protect against contamination<br />
with undesirable microorganisms) in an adequate hand-washing facility before starting<br />
work, after each absence from the work<br />
<strong>Food</strong> and Drug Administration, HHS § 110.20<br />
station, and at any other time when the hands may have become soiled or contaminated.<br />
(4) Removing all unsecured jewelry and other objects that might fall into food, equipment,<br />
or containers, and removing hand jewelry that cannot be adequately sanitized<br />
during periods in which food is manipulated by hand. If such hand jewelry cannot be<br />
removed, it may be covered by material which can be maintained in an intact, clean, and<br />
sanitary condition and which effectively protects against the contamination by these objects<br />
of the food, food-contact surfaces, or food-packaging materials.<br />
(5) Maintaining gloves, if they are used in food handling, in an intact, clean, and sanitary<br />
condition. The gloves should be of an impermeable material.<br />
(6) Wearing, where appropriate, in an effective manner, hair nets, headbands, caps,<br />
beard covers, or other effective hair restraints.<br />
(7) Storing clothing or other personal belongings in areas other than where food is<br />
exposed or where equipment or utensils are washed.<br />
(8) Confining the following to areas other than where food may be exposed or where<br />
equipment or utensils are washed: eating food, chewing gum, drinking beverages, or using<br />
tobacco.<br />
(9) Taking any other necessary precautions to protect against contamination of food,<br />
food-contact surfaces, or food-packaging materials with microorganisms or foreign substances<br />
including, but not limited to, perspiration, hair, cosmetics, tobacco, chemicals, and<br />
medicines applied to the skin.<br />
(c) Education and training. Personnel responsible for identifying sanitation failures or<br />
food contamination should have a background of education or experience, or a combination<br />
thereof, to provide a level of competency necessary for production of clean and safe<br />
food. <strong>Food</strong> handlers and supervisors should receive appropriate training in proper food<br />
handling techniques and food-protection principles and should be informed of the danger<br />
of poor personal hygiene and insanitary practices.<br />
(d) Supervision. Responsibility for assuring compliance by all personnel with all requirements<br />
of this part shall be clearly assigned to competent supervisory personnel.<br />
[51 FR 24475, June 19, 1986, as amended at 54 FR 24892, June 12, 1989]<br />
§ 110.19 Exclusions.<br />
(a) The following operations are not subject to this part: Establishments engaged solely<br />
in the harvesting, storage, or distribution of one or more ``raw agricultural commodities,’’<br />
as defined in section 201(r) of the act, which are ordinarily cleaned, prepared, treated, or<br />
otherwise processed before being marketed to the consuming public.<br />
(b) FDA, however, will issue special regulations if it is necessary to cover these excluded<br />
operations.<br />
Subpart B — Buildings and Facilities<br />
§ 110.20 Plant and grounds.<br />
(a) Grounds. The grounds about a food plant under the control of the operator shall be<br />
kept in a condition that will protect against the contamination of food. The methods for<br />
adequate maintenance of grounds include, but are not limited to:<br />
(1) Properly storing equipment, removing litter and waste, and cutting weeds or grass<br />
within the immediate vicinity of the plant buildings or structures that may constitute an<br />
attractant, breeding place, or harborage for pests.<br />
B<br />
APPENDIX<br />
29
Appendix B: <strong>Food</strong> and Drug Administration, HHS § 110.3<br />
(2) Maintaining roads, yards, and parking lots so that they do not constitute a source of<br />
contamination in areas where food is exposed.<br />
(3) Adequately draining areas that may contribute contamination to food by seepage,<br />
foot-borne filth, or providing a breeding place for pests.<br />
(4) Operating systems for waste treatment and disposal in an adequate manner so that<br />
they do not constitute a source of contamination in areas where food is exposed.<br />
If the plant grounds are bordered by grounds not under the operator’s control and not<br />
maintained in the manner described in paragraph (a) (1) through (3) of this section, care<br />
shall be exercised in the plant by inspection, extermination, or other means to exclude<br />
pests, dirt, and filth that may be a source of food contamination.<br />
B<br />
APPENDIX<br />
21 CFR Ch. 1 (4—1—01 Edition) § 110.35<br />
(b) Plant construction and design. Plant buildings and structures shall be suitable in size,<br />
construction, and design to facilitate maintenance and sanitary operations for food-manufacturing<br />
purposes. The plant and facilities shall:<br />
(1) Provide sufficient space for such placement of equipment and storage of materials<br />
as is necessary for the maintenance of sanitary operations and the production of safe<br />
food.<br />
(2) Permit the taking of proper precautions to reduce the potential for contamination<br />
of food, food-contact surfaces, or food-packaging materials with microorganisms, chemicals,<br />
filth, or other extraneous material. The potential for contamination may be reduced<br />
by adequate food safety controls and operating practices or effective design, including<br />
the separation of operations in which contamination is likely to occur, by one or more of<br />
the following means: location, time, partition, air flow, enclosed systems, or other effective<br />
means.<br />
(3) Permit the taking of proper precautions to protect food in outdoor bulk fermentation<br />
vessels by any effective means, including:<br />
(i) Using protective coverings.<br />
(ii) Controlling areas over and around the vessels to eliminate harborages for pests.<br />
(iii) Checking on a regular basis for pests and pest infestation.<br />
(iv) Skimming the fermentation vessels, as necessary.<br />
(4) Be constructed in such a manner that floors, walls, and ceilings may be adequately<br />
cleaned and kept clean and kept in good repair; that drip or condensate from fixtures,<br />
ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging<br />
materials; and that aisles or working spaces are provided between equipment and walls<br />
and are adequately unobstructed and of adequate width to permit employees to perform<br />
their duties and to protect against contaminating food or food-contact surfaces with<br />
clothing or personal contact.<br />
(5) Provide adequate lighting in hand-washing areas, dressing and locker rooms, and<br />
toilet rooms and in all areas where food is examined, processed, or stored and where<br />
equipment or utensils are cleaned; and provide safety-type light bulbs, fixtures, skylights,<br />
or other glass suspended over exposed food in any step of preparation or otherwise protect<br />
against food contamination in case of glass breakage.<br />
(6) Provide adequate ventilation or control equipment to minimize odors and vapors<br />
(including steam and noxious fumes) in areas where they may contaminate food; and<br />
locate and operate fans and other air-blowing equipment in a manner that minimizes the<br />
potential for contaminating food, food-packaging materials, and food-contact surfaces.<br />
(7) Provide, where necessary, adequate screening or other protection against pests.<br />
§ 110.35 Sanitary operations.<br />
(a) General maintenance. Buildings, fixtures, and other physical facilities of the plant<br />
shall be maintained in a sanitary condition and shall be kept in repair sufficient to prevent<br />
food from becoming adulterated within the meaning of the act. Cleaning and sanitizing<br />
of utensils and equipment shall be conducted in a manner that protects against contamination<br />
of food, food-contact surfaces, or food-packaging materials.<br />
(b) Substances used in cleaning and sanitizing; storage of toxic materials. (1) Cleaning<br />
compounds and sanitizing agents used in cleaning and sanitizing procedures shall be free<br />
from undesirable microorganisms and shall be safe and adequate under the conditions of<br />
30
Appendix B: <strong>Food</strong> and Drug Administration, HHS § 110.3<br />
use. Compliance with this requirement may be verified by any effective means including<br />
purchase of these substances under a supplier’s guarantee or certification, or examination<br />
of these substances for contamination. Only the following toxic materials may be used or<br />
stored in a plant where food is processed or exposed:<br />
(i) Those required to maintain clean and sanitary conditions;<br />
(ii) Those necessary for use in laboratory testing procedures;<br />
(iii) Those necessary for plant and equipment maintenance and operation; and<br />
(iv) Those necessary for use in the plant’s operations.<br />
<strong>Food</strong> and Drug Administration, HHS § 110.37<br />
(2) Toxic cleaning compounds, sanitizing agents, and pesticide chemicals shall be identified,<br />
held, and stored in a manner that protects against contamination of food, food-contact<br />
surfaces, or food-packaging materials. All relevant regulations promulgated by other<br />
Federal, State, and local government agencies for the application, use, or holding of these<br />
products should be followed.<br />
(c) <strong>Pest</strong> control. No pests shall be allowed in any area of a food plant. Guard or guide<br />
dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely to<br />
result in contamination of food, food-contact surfaces, or food-packaging materials. Effective<br />
measures shall be taken to exclude pests from the processing areas and to protect<br />
against the contamination of food on the premises by pests. The use of insecticides or<br />
rodenticides is permitted only under precautions and restrictions that will protect against<br />
the contamination of food, food-contact surfaces, and food-packaging materials.<br />
(d) Sanitation of food-contact surfaces. All food-contact surfaces, including utensils and<br />
food-contact surfaces of equipment, shall be cleaned as frequently as necessary to protect<br />
against contamination of food.<br />
(1) <strong>Food</strong>-contact surfaces used for manufacturing or holding low-moisture food shall<br />
be in a dry, sanitary condition at the time of use. When the surfaces are wet-cleaned, they<br />
shall, when necessary, be sanitized and thoroughly dried before subsequent use.<br />
(2) In wet processing, when cleaning is necessary to protect against the introduction of<br />
microorganisms into food, all food-contact surfaces shall be cleaned and sanitized before<br />
use and after any interruption during which the food-contact surfaces may have become<br />
contaminated. Where equipment and utensils are used in a continuous production operation,<br />
the utensils and food-contact surfaces of the equipment shall be cleaned and sanitized<br />
as necessary.<br />
(3) Non-food-contact surfaces of equipment used in the operation of food plants should<br />
be cleaned as frequently as necessary to protect against contamination of food.<br />
(4) Single-service articles (such as utensils intended for one-time use, paper cups, and<br />
paper towels) should be stored in appropriate containers and shall be handled, dispensed,<br />
used, and disposed of in a manner that protects against contamination of food or foodcontact<br />
surfaces.<br />
(5) Sanitizing agents shall be adequate and safe under conditions of use. Any facility,<br />
procedure, or machine is acceptable for cleaning and sanitizing equipment and utensils if<br />
it is established that the facility, procedure, or machine will routinely render equipment<br />
and utensils clean and provide adequate cleaning and sanitizing treatment.<br />
(e) Storage and handling of cleaned portable equipment and utensils. Cleaned and<br />
sanitized portable equipment with food-contact surfaces and utensils should be stored in<br />
a location and manner that protects food-contact surfaces from contamination.<br />
[51 FR 24475, June 19, 1986, as amended at 54 FR 24892, June 12, 1989]<br />
§ 110.37 Sanitary facilities and controls.<br />
Each plant shall be equipped with adequate sanitary facilities and accommodations<br />
including, but not limited to:<br />
(a) Water supply. The water supply shall be sufficient for the operations intended and<br />
shall be derived from an adequate source. Any water that contacts food or food-contact<br />
surfaces shall be safe and of adequate sanitary quality. Running water at a suitable temperature,<br />
and under pressure as needed, shall be provided in all areas where required<br />
for the processing of food, for the cleaning of equipment, utensils, and food-packaging<br />
materials, or for employee sanitary facilities.<br />
B<br />
APPENDIX<br />
31
Appendix B: <strong>Food</strong> and Drug Administration, HHS § 110.3<br />
(b) Plumbing. Plumbing shall be of adequate size and design and adequately installed<br />
and maintained to:<br />
(1) Carry sufficient quantities of water to required locations throughout the plant.<br />
(2) Properly convey sewage and liquid disposable waste from the plant.<br />
(3) Avoid constituting a source of contamination to food, water supplies, equipment, or<br />
utensils or creating an unsanitary condition.<br />
B<br />
APPENDIX<br />
21 CFR Ch. 1 (4—1—01 Edition) § 110.40<br />
(4) Provide adequate floor drainage in all areas where floors are subject to floodingtype<br />
cleaning or where normal operations release or discharge water or other liquid<br />
waste on the floor.<br />
(5) Provide that there is not backflow from, or cross-connection between, piping systems<br />
that discharge waste water or sewage and piping systems that carry water for food<br />
or food manufacturing.<br />
(c) Sewage disposal. Sewage disposal shall be made into an adequate sewerage system<br />
or disposed of through other adequate means.<br />
(d) Toilet facilities. Each plant shall provide its employees with adequate, readily accessible<br />
toilet facilities. Compliance with this requirement may be accomplished by:<br />
(1) Maintaining the facilities in a sanitary condition.<br />
(2) Keeping the facilities in good repair at all times.<br />
(3) Providing self-closing doors.<br />
(4) Providing doors that do not open into areas where food is exposed to airborne<br />
contamination, except where alternate means have been taken to protect against such<br />
contamination (such as double doors or positive air-flow systems).<br />
(e) Hand-washing facilities. Hand-washing facilities shall be adequate and convenient<br />
and be furnished with running water at a suitable temperature. Compliance with this<br />
requirement may be accomplished by providing:<br />
(1) Hand-washing and, where appropriate, hand-sanitizing facilities at each location in<br />
the plant where good sanitary practices require employees to wash and/or sanitize their<br />
hands.<br />
(2) Effective hand-cleaning and sanitizing preparations.<br />
(3) Sanitary towel service or suitable drying devices.<br />
(4) Devices or fixtures, such as water control valves, so designed and constructed to protect<br />
against recontamination of clean, sanitized hands.<br />
(5) Readily understandable signs directing employees handling unprotected food,<br />
unprotected food-packaging materials, of food-contact surfaces to wash and, where appropriate,<br />
sanitize their hands before they start work, after each absence from post of<br />
duty, and when their hands may have become soiled or contaminated. These signs may be<br />
posted in the processing room(s) and in all other areas where employees may handle such<br />
food, materials, or surfaces.<br />
(6) Refuse receptacles that are constructed and maintained in a manner that protects<br />
against contamination of food.<br />
(f) Rubbish and offal disposal. Rubbish and any offal shall be so conveyed, stored, and<br />
disposed of as to minimize the development of odor, minimize the potential for the waste<br />
becoming an attractant and harborage or breeding place for pests, and protect against<br />
contamination of food, food-contact surfaces, water supplies, and ground surfaces.<br />
Subpart C — Equipment<br />
§ 110.40 Equipment and utensils.<br />
(a) All plant equipment and utensils shall be so designed and of such material and<br />
workmanship as to be adequately cleanable, and shall be properly maintained. The design,<br />
construction, and use of equipment and utensils shall preclude the adulteration of<br />
food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants.<br />
All equipment should be so installed and maintained as to facilitate the cleaning of<br />
the equipment and of all adjacent spaces. <strong>Food</strong>-contact surfaces shall be corrosion-resistant<br />
when in contact with food. They shall be made of nontoxic materials and designed to<br />
withstand the environment of their intended use and the action of food, and, if applicable,<br />
cleaning compounds and sanitizing agents. <strong>Food</strong>-contact surfaces shall be maintained<br />
32
Appendix B: <strong>Food</strong> and Drug Administration, HHS § 110.3<br />
to protect food from being contaminated by any source, including unlawful indirect food<br />
additives.<br />
(b) Seams on food-contact surfaces shall be smoothly bonded or maintained so as to<br />
minimize accumulation of food particles, dirt, and organic matter and thus minimize the<br />
opportunity for growth of microorganisms.<br />
(c) Equipment that is in the manufacturing or food-handling area and that does not<br />
come into contact with food shall be so constructed that it can be kept in a clean condition.<br />
<strong>Food</strong> and Drug Administration, HHS § 110.80<br />
(d) Holding, conveying, and manufacturing systems, including gravimetric, pneumatic,<br />
closed, and automated systems, shall be of a design and construction that enables them to<br />
be maintained in an appropriate sanitary condition.<br />
(e) Each freezer and cold storage compartment used to store and hold food capable<br />
of supporting growth of microorganisms shall be fitted with an indicating thermometer,<br />
temperature-measuring device, or temperature-recording device so installed as to show<br />
the temperature accurately within the compartment, and should be fitted with an automatic<br />
control for regulating temperature or with an automatic alarm system to indicate a<br />
significant temperature change in a manual operation.<br />
(f) Instruments and controls used for measuring, regulating, or recording temperatures,<br />
pH, acidity, water activity, or other conditions that control or prevent the growth<br />
of undesirable microorganisms in food shall be accurate and adequately maintained, and<br />
adequate in number for their designated uses.<br />
(g) Compressed air or other gases mechanically introduced into food or used to clean<br />
food-contact surfaces or equipment shall be treated in such a way that food is not contaminated<br />
with unlawful indirect food additives.<br />
Subpart D [Reserved]<br />
Subpart E — Production and Process Controls<br />
§ 110.80 Processes and controls.<br />
All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing,<br />
packaging, and storing of food shall be conducted in accordance with adequate<br />
sanitation principles. Appropriate quality control operations shall be employed to ensure<br />
that food is suitable for human consumption and that food-packaging materials are safe<br />
and suitable. Overall sanitation of the plant shall be under the supervision of one or more<br />
competent individuals assigned responsibility for this function. All reasonable precautions<br />
shall be taken to ensure that production procedures do not contribute contamination<br />
from any source. Chemical, microbial, or extraneous-material testing procedures shall be<br />
used where necessary to identify sanitation failures or possible food contamination. All<br />
food that has become contaminated to the extent that it is adulterated within the meaning<br />
of the act shall be rejected, or if permissible, treated or processed to eliminate the<br />
contamination.<br />
(a) Raw materials and other ingredients. (1) Raw materials and other ingredients shall<br />
be inspected and segregated or otherwise handled as necessary to ascertain that they are<br />
clean and suitable for processing into food and shall be stored under conditions that will<br />
protect against contamination and minimize deterioration. Raw materials shall be washed<br />
or cleaned as necessary to remove soil or other contamination. Water used for washing,<br />
rinsing, or conveying food shall be safe and of adequate sanitary quality. Water may be<br />
reused for washing, rinsing, or conveying food if it does not increase the level of contamination<br />
of the food. Containers and carriers of raw materials should be inspected on<br />
receipt to ensure that their condition has not contributed to the contamination or deterioration<br />
of food.<br />
(2) Raw materials and other ingredients shall either not contain levels of microorganisms<br />
that may produce food poisoning or other disease in humans, or they shall be<br />
pasteurized or otherwise treated during manufacturing operations so that they no longer<br />
contain levels that would cause the product to be adulterated within the meaning of the<br />
act. Compliance with this requirement may be verified by any effective means, including<br />
B<br />
APPENDIX<br />
33
Appendix B: <strong>Food</strong> and Drug Administration, HHS § 110.3<br />
purchasing raw materials and other ingredients under a supplier’s guarantee or certification.<br />
(3) Raw materials and other ingredients susceptible to contamination with aflatoxin<br />
or other natural toxins shall comply with current <strong>Food</strong> and Drug Administration regulations<br />
and action levels for poisonous or deleterious substances before these materials or<br />
ingredients are incorporated into finished food. Compliance with this requirement may<br />
be accomplished by purchasing raw materials and other ingredients under a supplier’s<br />
guarantee or<br />
B<br />
APPENDIX<br />
21 CFR Ch. 1 (4—1—01 Edition) § 110.80<br />
certification, or may be verified by analyzing these materials and ingredients for aflatoxins<br />
and other natural toxins.<br />
(4) Raw materials, other ingredients, and rework susceptible to contamination with<br />
pests, undesirable microorganisms, or extraneous material shall comply with applicable<br />
<strong>Food</strong> and Drug Administration regulations and defect action levels for natural or unavoidable<br />
defects if a manufacturer wishes to use the materials in manufacturing food. Compliance<br />
with this requirement may be verified by any effective means, including purchasing<br />
the materials under a supplier’s guarantee or certification, or examination of these materials<br />
for contamination.<br />
(5) Raw materials, other ingredients, and rework shall be held in bulk, or in containers<br />
designed and constructed so as to protect against contamination and shall be held at<br />
such temperature and relative humidity and in such a manner as to prevent the food from<br />
becoming adulterated within the meaning of the act. Material scheduled for rework shall<br />
be identified as such.<br />
(6) Frozen raw materials and other ingredients shall be kept frozen. If thawing is required<br />
prior to use, it shall be done in a manner that prevents the raw materials and other<br />
ingredients from becoming adulterated within the meaning of the act.<br />
(7) Liquid or dry raw materials and other ingredients received and stored in bulk form<br />
shall be held in a manner that protects against contamination.<br />
(b) Manufacturing operations. (1) Equipment and utensils and finished food containers<br />
shall be maintained in an acceptable condition through appropriate cleaning and sanitizing,<br />
as necessary. Insofar as necessary, equipment shall be taken apart for thorough cleaning.<br />
(2) All food manufacturing, including packaging and storage, shall be conducted under<br />
such conditions and controls as are necessary to minimize the potential for the growth of<br />
microorganisms, or for the contamination of food. One way to comply with this requirement<br />
is careful monitoring of physical factors such as time, temperature, humidity, aw,<br />
pH, pressure, flow rate, and manufacturing operations such as freezing, dehydration, heat<br />
processing, acidification, and refrigeration to ensure that mechanical breakdowns, time<br />
delays, temperature fluctuations, and other factors do not contribute to the decomposition<br />
or contamination of food.<br />
(3) <strong>Food</strong> that can support the rapid growth of undesirable microorganisms, particularly<br />
those of public health significance, shall be held in a manner that prevents the food from<br />
becoming adulterated within the meaning of the act. Compliance with this requirement<br />
may be accomplished by any effective means, including:<br />
(i) Maintaining refrigerated foods at 45 deg.F (7.2 deg.C) or below as appropriate for<br />
the particular food involved.<br />
(ii) Maintaining frozen foods in a frozen state.<br />
(iii) Maintaining hot foods at 140 deg. F (60 deg. C) or above.<br />
(iv) Heat treating acid or acidified foods to destroy mesophilic microorganisms when<br />
those foods are to be held in hermetically sealed containers at ambient temperatures.<br />
(4) Measures such as sterilizing, irradiating, pasteurizing, freezing, refrigerating, controlling<br />
pH or controlling aw that are taken to destroy or prevent the growth of undesirable<br />
microorganisms, particularly those of public health significance, shall be adequate<br />
under the conditions of manufacture, handling, and distribution to prevent food from<br />
being adulterated within the meaning of the act.<br />
(5) Work-in-process shall be handled in a manner that protects against contamination.<br />
(6) Effective measures shall be taken to protect finished food from contamination by<br />
34
Appendix B: <strong>Food</strong> and Drug Administration, HHS § 110.3<br />
raw materials, other ingredients, or refuse. When raw materials, other ingredients, or<br />
refuse are unprotected, they shall not be handled simultaneously in a receiving, loading,<br />
or shipping area if that handling could result in contaminated food. <strong>Food</strong> transported by<br />
conveyor shall be protected against contamination as necessary.<br />
(7) Equipment, containers, and utensils used to convey, hold, or store raw materials,<br />
work-in-process, rework, or food shall be constructed, handled, and maintained during<br />
manufacturing or<br />
<strong>Food</strong> and Drug Administration, HHS § 110.80<br />
storage in a manner that protects against contamination.<br />
(8) Effective measures shall be taken to protect against the inclusion of metal or other<br />
extraneous material in food. Compliance with this requirement may be accomplished by<br />
using sieves, traps, magnets, electronic metal detectors, or other suitable effective means.<br />
(9) <strong>Food</strong>, raw materials, and other ingredients that are adulterated within the meaning<br />
of the act shall be disposed of in a manner that protects against the contamination of<br />
other food. If the adulterated food is capable of being reconditioned, it shall be reconditioned<br />
using a method that has been proven to be effective or it shall be reexamined and<br />
found not to be adulterated within the meaning of the act before being incorporated<br />
into other food.<br />
(10) Mechanical manufacturing steps such as washing, peeling, trimming, cutting, sorting<br />
and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping,<br />
defatting, and forming shall be performed so as to protect food against contamination.<br />
Compliance with this requirement may be accomplished by providing adequate<br />
physical protection of food from contaminants that may drip, drain, or be drawn into the<br />
food. Protection may be provided by adequate cleaning and sanitizing of all food-contact<br />
surfaces, and by using time and temperature controls at and between each manufacturing<br />
step.<br />
(11) Heat blanching, when required in the preparation of food, should be effected<br />
by heating the food to the required temperature, holding it at this temperature for the<br />
required time, and then either rapidly cooling the food or passing it to subsequent manufacturing<br />
without delay. Thermophilic growth and contamination in blanchers should<br />
be minimized by the use of adequate operating temperatures and by periodic cleaning.<br />
Where the blanched food is washed prior to filling, water used shall be safe and of adequate<br />
sanitary quality.<br />
(12) Batters, breading, sauces, gravies, dressings, and other similar preparations shall be<br />
treated or maintained in such a manner that they are protected against contamination.<br />
Compliance with this requirement may be accomplished by any effective means, including<br />
one or more of the following:<br />
(i) Using ingredients free of contamination.<br />
(ii) Employing adequate heat processes where applicable.<br />
(iii) Using adequate time and temperature controls.<br />
(iv) Providing adequate physical protection of components from contaminants that may<br />
drip, drain, or be drawn into them.<br />
(v) Cooling to an adequate temperature during manufacturing.<br />
(vi) Disposing of batters at appropriate intervals to protect against the growth of microorganisms.<br />
(13) Filling, assembling, packaging, and other operations shall be performed in such a<br />
way that the food is protected against contamination. Compliance with this requirement<br />
may be accomplished by any effective means, including:<br />
(i) Use of a quality control operation in which the critical control points are identified<br />
and controlled during manufacturing.<br />
(ii) Adequate cleaning and sanitizing of all food-contact surfaces and food containers.<br />
(iii) Using materials for food containers and food- packaging materials that are safe and<br />
suitable, as defined in Sec. 130.3(d) of this chapter.<br />
(iv) Providing physical protection from contamination, particularly airborne contamination.<br />
(v) Using sanitary handling procedures.<br />
(14) <strong>Food</strong> such as, but not limited to, dry mixes, nuts, intermediate moisture food, and<br />
B<br />
APPENDIX<br />
35
Appendix B: <strong>Food</strong> and Drug Administration, HHS § 110.3<br />
dehydrated food, that relies on the control of aw for preventing the growth of undesirable<br />
microorganisms shall be processed to and maintained at a safe moisture level.<br />
Compliance with this requirement may be accomplished by any effective means, including<br />
employment of one or more of the following practices:<br />
(i) Monitoring the aw of food.<br />
(ii) Controlling the soluble solids-water ratio in finished food.<br />
(iii) Protecting finished food from moisture pickup, by use of a moisture barrier or by<br />
other means, so that the<br />
21 CFR Ch. 1 (4—1—01 Edition) § 110.93<br />
aw of the food does not increase to an unsafe level.<br />
(15) <strong>Food</strong> such as, but not limited to, acid and acidified food, that relies principally<br />
on the control of pH for preventing the growth of undesirable microorganisms shall be<br />
monitored and maintained at a pH of 4.6 or below. Compliance with this requirement<br />
may be accomplished by any effective means, including employment of one or more of<br />
the following practices:<br />
(i) Monitoring the pH of raw materials, food in process, and finished food.<br />
(ii) Controlling the amount of acid or acidified food added to low-acid food.<br />
(16) When ice is used in contact with food, it shall be made from water that is safe and<br />
of adequate sanitary quality, and shall be used only if it has been manufactured in accordance<br />
with current good manufacturing practice as outlined in this part.<br />
(17) <strong>Food</strong>-manufacturing areas and equipment used for manufacturing human food<br />
should not be used to manufacture nonhuman food-grade animal feed or inedible products,<br />
unless there is no reasonable possibility for the contamination of the human food.<br />
[51 FR 24475, June 19, 1986, as amended at 65 FR 56479, Sept. 19, 2000]<br />
§ 110.93 Warehousing and distribution.<br />
Storage and transportation of finished food shall be under conditions that will protect<br />
food against physical, chemical, and microbial contamination as well as against deterioration<br />
of the food and the container.<br />
Subpart F [Reserved]<br />
B<br />
APPENDIX<br />
Subpart G — Defect Action Levels<br />
§ 110.110 Natural or unavoidable defects in food for human use that present no health<br />
hazard.<br />
(a) Some foods, even when produced under current good manufacturing practice,<br />
contain natural or unavoidable defects that at low levels are not hazardous to health.<br />
The <strong>Food</strong> and Drug Administration establishes maximum levels for these defects in foods<br />
produced under current good manufacturing practice and uses these levels in deciding<br />
whether to recommend regulatory action.<br />
(b) Defect action levels are established for foods whenever it is necessary and feasible<br />
to do so. These levels are subject to change upon the development of new technology or<br />
the availability of new information.<br />
(c) Compliance with defect action levels does not excuse violation of the requirement<br />
in section 402(a)(4) of the act that food not be prepared, packed, or held under unsanitary<br />
conditions or the requirements in this part that food manufacturers, distributors,<br />
and holders shall observe current good manufacturing practice. Evidence indicating that<br />
such a violation exists causes the food to be adulterated within the meaning of the act,<br />
even though the amounts of natural or unavoidable defects are lower than the currently<br />
established defect action levels. The manufacturer, distributor, and holder of food shall at<br />
all times utilize quality control operations that reduce natural or unavoidable defects to<br />
the lowest level currently feasible.<br />
(d) The mixing of a food containing defects above the current defect action level with<br />
another lot of food is not permitted and renders the final food adulterated within the<br />
meaning of the act, regardless of the defect level of the final food.<br />
(e) A compilation of the current defect action levels for natural or unavoidable defects<br />
in food for human use that present no health hazard may be obtained upon request from<br />
36
Appendix B: <strong>Food</strong> and Drug Administration, HHS § 110.3<br />
the Center for <strong>Food</strong> Safety and Applied Nutrition (HFS-565), <strong>Food</strong> and Drug Administration,<br />
5100 Paint Branch Pkwy., College Park, MD 20740.<br />
[51 FR 24475, June 19, 1986, as amended at 61 FR 14480, Apr. 2, 1996; 66 FR 56035, Nov. 6,<br />
2001]<br />
PART 111— CURRENT GOOD MANUFACTURING PRACTICE FOR DIETARY<br />
SUPPLEMENTS<br />
AUTHORITY: 21 U.S.C. 321, 342, 371.<br />
SOURCE: 62 FR 2249, Jan. 15, 1997, unless otherwise noted.<br />
This electronic document was downloaded from the GPO web site, May 2004, and is<br />
provided for information purposes only. The Code of Federal Regulations, Title 21, is<br />
updated each year in early summer. The most current version of the regulations may be<br />
found at the GPO web site or from the current printed version.<br />
B<br />
APPENDIX<br />
37
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41
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